Device recall
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
- Recall number
- Z-3229-2026
- Event id
- 99729
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Aug 10, 2026
- Center classification date
- Sep 18, 2026
- Product code
- LRO
- Device type
- General Surgery Tray
- Reason
- Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.
- Root cause
- Under Investigation by firm
- Quantity
- 90 kits (US)
- Code info
- DYNJ48258D UDI-DI 10889942563272 Lots 23CBH459 23GBJ128 24ABM400
- Distribution
- US Nationwide distribution in the states of MN and SD.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K213481
- Location
- Northfield, IL, United States